Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (November 2014)
33 slides from Lipocine's investor presentation, Nov 26, 2014
Slide 1: Corporate Presentation December 2014
Corporate Presentation December 2014 Exhibit 99.1
Slide 2: Forward-looking statements
2 This presentation contains and our discussions during this conference may include forward - looking statements about Lipocine Inc. (the “Company”). These forward - looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forw
Slide 3: Lipocine Corporate Highlights
3 Lipocine Corporate Highlights Focused on innovative products for men’s and women’s health • “Transformative“ oral testosterone franchise • Oral alternative for the prevention of pre - term birth Technology platform capable of “multiple hits” Lead asset in Phase 3 • Positive top - line effica
Slide 4: Product Pipeline
4 Product Pipeline LPCN 1021 - Oral Testosterone Replacement Therapy (TRT) Men’s Health LPCN 1111 - Next Generation Oral TRT Women’s Health LPCN 1107 - Pregnancy Support: Prevention of Preterm Birth Research/Preclinical Phase 1 Phase 2 Phase 3
Slide 5: Lip'ral Enables Optimal Dispersion in the Gastrointestinal Tract
5 Lip’ral Enables Optimal Dispersion in the Gastrointestinal Tract Lumen Aqueous Barrier Layer Membrane Systemic Circulation Improved absorption Effective transfer across aqueous barrier layer Optimal dispersed phase in GI tract Insoluble drug lipidic composition 5
Slide 6: Near Term Value Drivers
6 Near Term Value Drivers 4Q 2014 1 Q 2015 2 Q 2015 3 Q 2015 4Q 2015 LPCN 1021: Complete Phase 3 with Safety Data LPCN 1021: File NDA LPCN 1111: Initiate Phase 2B Study LPCN 1107: Top Line Results Phase 1B Study
Slide 7: Testosterone Deficiency is Prevalent in U.S.
7 Testosterone Deficiency is Prevalent in U.S. 1 (1) Rev. Urol Vol 5. Suppl 1 2003 S3 - S10 - Figure 2 (2) Archive of Internal Medicine 2008 • Men in their 50s 1 in 10 • Men in their 60s 1 in 5 • Men in their 70s 1 in 4 Only 12% of Men with Low T Receive TRT 2
Slide 8: Testosterone Replacement Therapy Market
8 US market > $2.3B in 2013 1 International markets for TRT growing Current TRT “class label” under review by FDA Topicals dominate the market (~89 % of $ sales) • Inadvertent transference issue, black box warning • Poor compliance: 86 % discontinue at 12 months 1 Existing testosterone tre
Slide 9: TRT Advisory Committee Meeting
9 TRT Advisory Committee Meeting Topics for Discussion • Appropriate population for testosterone replacement therapy • Potential for adverse cardiovascular outcomes associated with TRT Recommendations • Voted in favor of revising the current label for testosterone therapy • Recommended that comp
Slide 10: EMA PRAC review of testosterone
10 EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) review • Did not find consistent evidence that T use increases the risk of heart problems • Benefits of testosterone continue to outweigh its risks • Recommended that testosterone use should only occur after the lack of testosterone has b
Slide 11: LPCN 1021: Oral Treatment Option for TRT
11 Novel product primarily directed at lymphatic delivery of Testosterone Undecanoate (TU) Enhanced profile over other forms of testosterone (T) • Methyl T is known to have liver safety issues • Natural T has short half life Maintains effective T blood levels when dosed BID Target label — co
Slide 12: Current Regulatory Paradigm
12 Current Regulatory Paradigm 1 Meet primary end points • Responder analysis relating to average serum concentration 0 to 24 hours ( C avg ) and lower bound Confidence Interval (CI) Acceptable safety profile • Responder analysis relating to peak testosterone levels that is consistent with appro
Slide 13: SOAR Trial - Phase 3 Study Design
13 Open label, randomized, active - controlled study of LPCN 1021 in men with low T Study of Oral Androgen Replacement (SOAR) Trial - Phase 3 Study Design Screening N = 315 0 Week 4 Week 8 Randomization LPCN 1021 225mg, TU, BID w/ meal (n = 210) Active Control (n = 105) PK /dose titration PK /dose
Slide 14: SOAR Trial - Dataset Definition
14 Primary Analysis Set • Efficacy Population (N=152): Subjects randomized into the study with at least one PK profile and no significant protocol deviations x Imputed missing data by Last Observation Carried Forward (LOCF) Additional Analysis Set • Safety Set (N=210): Subjects randomized into t
Slide 15: SOAR Trial - Primary Endpoint: Responder Analysis and Cavg
15 SOAR Trial - Primary Endpoint: Responder Analysis and C avg Measure Efficacy Population Safety Set Number of subjects 152 210 % subjects with C avg w ithin normal range 88.2% 80.0% 95 % CI lower bound 81.9% 73.8% Parameter Mean (%CV) C avg ( ng / dL ) 447 (37%) Primary endpoint target ≥ 75% sub
Slide 16: SOAR Trial - Final Dose Distribution of Subjects
16 Dose (mg TU, BID) % of subjects 150 36% 225* 51% 300 13% SOAR Trial - Final Dose Distribution of Subjects Dataset: Efficacy population, N=152 *starting dose x Majority of subjects with final dose of 225 mg BID
Slide 17: SOAR Trial - Titration Outcome
17 SOAR Trial - Titration Outcome Dataset: Efficacy population, N=152 Parameter % of subjects % subjects requiring no more than one dose change (either after week 3 or week 7) 85% % subjects requiring two dose changes (both after week 3 and 7) 15% x Vast majority of subjects reached final dose with
Slide 18: SOAR Trial - Secondary Endpoints
18 SOAR Trial - Secondary Endpoints Measure FDA Threshold Efficacy Population Number of subjects 152 C max < 1500 ng/ dL ≥ 85 % 82.9% 1800 ≤ C max ≤ 2500 ng/ dL ≤ 5 % 4.6% C max > 2500 ng/ dL None 2.0% Proportion of subjects achieving maximum serum total T concentrations (C max ) in predefined C m
Slide 19: SOAR Trial - Excessive T Repletion Outliers
19 Excessive T repletion outliers were observed in three subjects These observed excessive T repletion outliers were transient, sporadic, isolated, and not clinically meaningful • Lack of dose or dosing time dependency • None of these subjects reported any adverse events SOAR Trial - LPCN 1021 E
Slide 20: SOAR Trial - Adverse Events Summary
20 Safety study is on - going 3% of the subjects reported a serious adverse event • There were no drug related Serious AEs 46% of the subjects experienced at least one adverse event • Approximately one third of these events were drug related • All these adverse events were either mild or moder
Slide 21: SOAR Trial - LPCN 1021 Top Line Phase 3 Results Summary
21 Unequivocally met primary efficacy end point Patient friendly dosing regimen • No more than one titration required in 85% of the subjects • Starting dose was the right dose for majority of the subjects Variability consistent with or better than approved products Consistent intra/inter day
Slide 22: Oral Expected to Improve Compliance and Patient Retention
22 Survey of 28 leading endocrinologists and urologists about oral testosterone compliance 1 • In your opinion, will oral testosterone improve patient compliance compared to existing options? Oral T is expected to increase per patient revenue through better retention rates Oral Expected to Impro
Slide 23: LPCN 1021: A "Safer" TRT Option
23 LPCN 1021: A “Safer” TRT Option Transfer potential to children, partner and pets No freedom to use around pregnant loved ones Skin irritation potential Lung impairment potential Scarring/injection site reactions Risk of infection Not flexible for dose reversals x No risk of transfer
Slide 24: LPCN 1021: Life "Uninterrupted" with Oral T
24 LPCN 1021: Life “Uninterrupted” with Oral T x Discrete x No waiting • Prior to dressing • In doctor’s office x Suitable for “on the go” use x No shower/swim restrictions x No mess/clean up x Non invasive Improved Compliance Convenience Enhanced Efficacy Higher Retention Rates
Slide 25: Competitive Environment for Oral Testosterone
25 Competitive Environment for Oral Testosterone Rextoro™: Clarus Therapeutics Current Status • Advisory Committee voted 18 - 3 that the overall benefit/risk profile of Rextoro® did not support approval • PDUFA date was November 3, 2014 - no announcement of approval LPCN 1021 Advantages • Unequivoca
Slide 26: LPCN 1111: Next Generation Oral Testosterone
26 Novel prodrug of testosterone for oral delivery through proprietary Lip’ral technology Maintains effective T blood levels when dosed once daily Status • Positive Phase 2a study results in hypogonadal men – Single daily oral dose provides T levels in the eugonadal range – No subject exceeded
Slide 27: LPCN 1111: Phase 2a Study in Hypogonadal Men
27 Five arm, sequential ascending dose study (N=12) • 3 single dose QD arms, (330mg, 550mg and 770mg TT) • 2 multiple dose QD arms for 28 days (550mg and 770mg TT) Successful outcomes • Demonstrated that once daily dosing is feasible • Good dose response • Steady state achieved by day 14 • No su
Slide 28: LPCN 1111 Phase 2a Study - Responder Analysis
28 LPCN 1111 Phase 2a Study - Responder Analysis At Day 28 Measure 550mg QD 770mg QD Typical FDA targets for approval of TRT % subjects with C avg w ithin normal range 67% 88% ≥ 75% % of subjects with C max ≤ 1500ng/ dL 100% 100% ≥ 85% % of subjects with C max between 1800ng/ dL and 2500mg/dl 0% 0%
Slide 29: Preterm Birth Represents a Significant Unmet Medical Need
29 Preterm Birth (PTB) Represents a Significant Unmet Medical Need One Preterm Infant per Minute in the US 1 □ 11.7% of all US pregnancies 2 result in PTB - a leading cause of mortality and morbidity 3 □ ~10x more first year medical costs are for PTB infants than for full term infants 4 □ ≥ $26 bill
Slide 30: LPCN 1107: Oral Candidate for Prevention of Preterm Birth
30 Potential to be the first oral standard - of care therapy • Same API as in the only approved injectable product • Elimination of 18 - 22 injections • Potential for orphan drug designation Status • Successful Phase 1a POC study • Phase 1b pharmacokinetic study in pregnant women ongoing – Top l
Slide 31: LPCN 1107: Phase 1a Study in Healthy Non-Pregnant Females
31 Randomized cross - over design(N=10) • Single dose, 400 mg LPCN 1107 • Two doses, 400 mg LPCN 1107 administered 12 hours apart • Single dose of 250 mg IM HPC Successful outcomes • Significant absorption with good dose response upon oral dosing of LPCN 1107 • LPCN 1107 oral steady state 400mg
Slide 32: Lipocine is a Compelling Value Proposition
32 Lipocine is a Compelling Value Proposition Stock Exchange NASDAQ Capital Markets Ticker Symbol LPCN Last Reported Stock Price (11/24/14) $5.15/share Market Capitalization (11/24/14) $65.8 million Fully Diluted Shares Outstanding (11/24/14) 14,346,876 Warrants Outstanding 0.14% Cash Balance (9/30/
Slide 33: Lipocine Corporate Highlights
33 Lipocine Corporate Highlights Focused on innovative products for men’s and women’s health • “Transformative“ oral testosterone franchise • Oral alternative for the prevention of pre - term birth Technology platform capable of “multiple hits” Lead asset in Phase 3 • Positive top - line effic